Relapsed and refractory mature B-cell non-Hodgkin Lymphoma
Conditions
Brief summary
Treatment Arm I: BsAb: Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria), Treatment Arm II: ADC with standard chemotherapy: Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)
Detailed description
Event-free survival time (EFS), Progression-free survival time (PFS), Overall survival time (OS), Best overall response (BOR) during treatment, Duration of response (DOR), Occurrence of an objective response (OR), where relevant, Occurrence of adverse events of special interest (AESI), Occurrence of treatment emergent adverse events (TEAEs), where relevant, Pharmacokinetic profile of novel agent, where relevant, Pharmacodynamic markers, where relevant
Interventions
DRUGDEXAMETHASONE
DRUGIFOSFAMIDE
DRUGETOPOSIDE
DRUGETOPOSIDE PHOSPHATE
DRUGOdronextamab
DRUGCARBOPLATIN
DRUGRITUXIMAB
Sponsors
The University Of Birmingham
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Arm I: BsAb: Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria), Treatment Arm II: ADC with standard chemotherapy: Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival time (EFS), Progression-free survival time (PFS), Overall survival time (OS), Best overall response (BOR) during treatment, Duration of response (DOR), Occurrence of an objective response (OR), where relevant, Occurrence of adverse events of special interest (AESI), Occurrence of treatment emergent adverse events (TEAEs), where relevant, Pharmacokinetic profile of novel agent, where relevant, Pharmacodynamic markers, where relevant | — |
Countries
Austria, Belgium, Netherlands, Sweden
Outcome results
None listed